Personal Information
Organization / Workplace
Greater New York City Area, Andhra Pradesh United States
Industry
Medical / Health Care / Pharmaceuticals
Website
http://www.makrocare.com
About
Preparing regulatory strategies in order to get approval from regulatory authorities.
Review and provide input into submission documents to ensure quality and accurate support of the regional and global regulatory strategy
Assisting internal and external team in preparation of dossier
Providing correct input to regulatory team to get timely approvals
Tags
central monitoring in clinical trial
rbm in clinical trial
clinical data management
clinical trials
corono visrus labeling requirements
fda new guidance for device labeling
medical device labeling
statistics clinical sap
sas biostatics outsourcing india
sas programming
statistical programming service
software verification and validation (samd )
ivdr requiremts for software
samd clinical evaluation process
pmcf data quality chalenges
post marketing clinical followup challenges
post marketing clinical followup
covid 19 labelling requirements
global labeling for medical device
clinical evaluation report
medical device clinical evaluation report
cer clinical evaluation report
centralized monitoring in clinical trial
sas programming outsourcing
cro india
biostatistics india
sas programming india
biostatistics outsourcing
psur writing
drug safety and pharmacovigilance
safety medical review and many other services
literature search
irbiec approval
site management
protocol compliance
ich-gcp
medical writing india
medical communications
manuscript writing
cmc writing out sourcing
medical writing outsourcing india
edc study setup
edc india
electronic data capture
case report form crf design
data management planning
cdm outsourcing india
cdm
regulatory strategy
regulatory publishing
regulatory compliance services
regulatory affairs
site management organization
patient recruitment management
cns central nervous system
See more
Presentations
(2)Documents
(3)Personal Information
Organization / Workplace
Greater New York City Area, Andhra Pradesh United States
Industry
Medical / Health Care / Pharmaceuticals
Website
http://www.makrocare.com
About
Preparing regulatory strategies in order to get approval from regulatory authorities.
Review and provide input into submission documents to ensure quality and accurate support of the regional and global regulatory strategy
Assisting internal and external team in preparation of dossier
Providing correct input to regulatory team to get timely approvals
Tags
central monitoring in clinical trial
rbm in clinical trial
clinical data management
clinical trials
corono visrus labeling requirements
fda new guidance for device labeling
medical device labeling
statistics clinical sap
sas biostatics outsourcing india
sas programming
statistical programming service
software verification and validation (samd )
ivdr requiremts for software
samd clinical evaluation process
pmcf data quality chalenges
post marketing clinical followup challenges
post marketing clinical followup
covid 19 labelling requirements
global labeling for medical device
clinical evaluation report
medical device clinical evaluation report
cer clinical evaluation report
centralized monitoring in clinical trial
sas programming outsourcing
cro india
biostatistics india
sas programming india
biostatistics outsourcing
psur writing
drug safety and pharmacovigilance
safety medical review and many other services
literature search
irbiec approval
site management
protocol compliance
ich-gcp
medical writing india
medical communications
manuscript writing
cmc writing out sourcing
medical writing outsourcing india
edc study setup
edc india
electronic data capture
case report form crf design
data management planning
cdm outsourcing india
cdm
regulatory strategy
regulatory publishing
regulatory compliance services
regulatory affairs
site management organization
patient recruitment management
cns central nervous system
See more